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The Orthofix Galaxy Wrist external fixator is an orthopedic device intended to be used for bone stabilization in trauma and orthopedic procedures, both on adults and pediatric patients as required.
The indications for use include:

• intra-articular or extra-articular fractures and dislocations of the wrist with or without soft tissue damage:
• polytrauma;
• carpal dislocations;
• unreduced fractures following conservative treatment;
• bone-loss or other reconstructive procedures:
• infection.

The Orthofix Galaxy Wrist is a complimentary system for the current Galaxy Fixation system, engineered specifically for the wrist. The primary objective of the Galaxy Wrist is to offer the possibility of distraction/compression and the mobilization of the joint. The device includes various frames, bars, clamps, accessories and instruments. The system is designed to be used with commercially available Orthofix pins. The clamps enable the frame to be coupled to bone by securing the pins/wires for the intended use. The system allows the surgeon to: - Position screws where the condition of the bone and soft tissues permits - Reduce the fracture in order to restore alignment

This is a 510(k) premarket notification for a medical device (Orthofix Galaxy Wrist external fixator), not a study evaluating an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design, expert consensus, and training/test set details for an AI model is not present in the provided document.

The document describes the device's indications for use, technological characteristics, and performance data related to mechanical testing and MRI compatibility, demonstrating substantial equivalence to predicate devices. It explicitly states that "Clinical data was not needed to support the safety and effectiveness of the Subject Device."

Therefore, I cannot provide the requested information.

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